INSTRUCTION MANUAL
This manual is valid for the TM In TENSity 5000 TENS Stimulator This user manual is published by Current Solutions, LLC Current Solutions, LLC does not guarantee its contents and reserves the right to improve and amend it at any time without prior notice. Amendments may however be published in new editions of this manual. All Rights Reserved.Rev.V1.0 2011 : United States Federal Law restricts this device to sale by or on the order of a physician or licensed practitioner Conformity to safety standards Current Solutions, LLC declares that the device complies with following normative documents: IEC60601-1, IEC60601-1-2, I EC60601-2-10, IEC60601-1-4, ISO10993-5, ISO10993-10, ISO10993-1
TABLE OF CONTENTS 1. INTRODUCTION...4 1.1 General 1.2 Medical background 2. PARTS... 6 3. GENERAL WARNINGS AND SAFETY...8 4. INSTRUCTIONS FOR USE... 11 4.1 Battery 4.2 Connect electrodes to lead wires 4.3 Connect lead wires to device 4.4 Electrode 4.5 Turn the device on: 4.6 Select the therapy mode: 4.7 Adjust the pulse width and pulse rate: 4.8 Select therapy time: 4.9 Adjust Channel intensity 4.10 Safety Lock Feature 4.11 Turn the device off 5. SPECIFICATION...17 5.1 Technical information: 5.2 The waveforms of the stimulation programs 6. Program... 20 7. Cleaning and Care...20 7.1 Tips for skin care 7.2 Cleaning the device 7.3 Electrodes 7.4 Cleaning the Electrodes cords 7.5 Maintenance 8. TROUBLESHOOTING... 24 9. MAINTENANCE AND CAUTIONS... 26 10. STORAGE...26 11. DISPOSAL...27 12. GLOSSARY OF SYMBOLS...27 13. WARRANTY...27 3
1. INTRODUCTION 1.1 General TM (ante ior neck) or transcerebra TM 1.2 Medical background EXPLANATION OF PAIN (anterior neck) or transcerebrally (through the 4
EXPLANATION OF TENS (anterior neck) or transcerebrally (through the head). HOW TENS WORK (anterior neck) or transcerebrally (through the head). 5
2. PARTS TM About InTENSity 5000 TM nterior neck) o ough th Main Unit Parts 15 16 1 2 3 5 4 6 17 7 8 10 9 11 19 12 13 14 18 (anterior neck) or transcerebrally (through the head). 6
(anterior neck) or transcerebrally (through the head) 7
3. GENERAL WARNINGS AND SAFETY Before you start (anterior neck) or Contraindications Warnings (anter or neck) or transcerebrally (through the he 8
(anterior neck) or transcerebrally (through the head). Precautions (anterior neck) or transcerebrally (through the head). 9
(anterior neck) or transcerebrally (through Adverse Reactions (anterior neck) o transcerebrally (through the head) 10
4. INSTRUCTIONS FOR USE 4.1 Battery 4.1.1 Check/Replace the battery (anterio neck) or transcerebrally (throu 9V 6F22 4.1.2 Disposal of battery CAUTION: (anterior neck) or transcerebrally (through the head). 11
(anterior neck) or transcerebrally (through the head). 4.2 Connect electrodes to lead wires Connection Cables Transparent Film CAUTION: 12
4.3 Connect lead wires to device 1) 2) 3) 4) Before proceeding to this step, be sure the device is completely turned OFF. Insert the wires provided with the system into the jack sockets located on top of the device. Holding the insulated portion of the connector, push the plug end of the wire into one of the jacks (see drawing); one or two sets of wires may be used. This device has two output receptacles controlled by Channel 1 and Channel 2 at the top of the unit. You may choose to use one channel with one pair of lead wires or both channels with two pairs of lead wires. Using both channels gives the user the advantage of stimulating two different areas at the same time. CAUTION: 4.4 Electrode 4.4.1 Electrode options The electrodes are disposable and should be routinely replaced when they start to lose their adhesive nature. If you are unsure of your electrodes adhesive properties, order replacement electrodes. Replacement electrodes should be re-ordered through or on the advice of your physician to ensure proper quality. Follow application procedures outlined in electrode packing, to maintain optimal stimulation and to prevent skin irritation. 13
4.4.2 Place electrode pads on skin Apply electrodes to the exact site indicated by your physician or therapist. Before applying electrodes, be sure the skin surface over which electrodes are placed is thoroughly clean and dry. Make sure the electrodes are pressed firmly to the skin and make good contact between the skin and the electrodes. Place the electrodes over the skin; attach them properly, firmly, and evenly. CAUTION: (anterior neck) or transcerebrally (through the he 4.4.3 Electrode placement The placement of electrodes can be one of the most important parameters in achieving success with therapy. Of utmost importance is the willingness of the physician to try the various styles of electrode placement to find which method best fits the needs of the individual patient. 14
Every patient responds to electrical stimulation differently and their needs may vary from the conventional settings suggested here. If the initial results are not positive, speak to your physician about alternative stimulation settings and/or electrode placements. Once an acceptable location has been achieved, mark down the electrode sites and the device settings, so the patient can easily continue treatment. 4.5 Turn the device on In order to turn on the device, press [ON/OFF] button, mode LED indicator and timer LED indicator will light up. 4.6 Select the therapy mode (anterior neck) or transcerebrally (through the hea 4.7 Adjust the pulse width and pulse rate By turning the [P. W.] knob clockwise to select pulse width, the pulse width is adjustable from 30 us to 260 us. By turning the [P. R.] knob clockwise to select pulse rate, the pulse rate is adjustable from 2 Hz to 150 Hz. 4.8 Select therapy time There are 4 therapy time (15, 30, 60, C) for you to select. Press the [TIMER] button, the appropriate time LED indicator will be light. Press [MODE] button cycle to select the therapy time. 15
4.9 Adjust Channel intensity Press the intensity control button [ ] and [ ] to control the intensity output and you will hear a beep sound. Slowly press the intensity button control until you reach the setting recommended by your physician or therapist. Repeat for the other channel, if both channels are used. CAUTION: 1) The maximum output intensity level is 10. 2) The therapy mode and therapy time LED indicator will flash in this state. 4.10 Safety Lock Feature (anterior neck) or transcerebrally (through the he 4.11 Turn the device off 16
5. SPECIFICATION 5.1 Technical information 01 02 03 04 05 06 07 08 09 10 11 12 13 Mechanism Channel Power Supply Pulse Amplitude Pulse Rate Pulse Width Voltage Wave Form Size Weight Timer Burst (B) Normal Mode (N) Modulation 1 mode (M1) Technical description Dual, isolated between channels One 9 Volt Battery Adjustable,0-80 ma peak into 500 ohm load each channel Adjustable, from 2 to 150 Hz Burst rate: 0.5Hz (Burst mode) Adjustable, from 30 to 260 microseconds 0 to 40 V (Load : 500 ohm) Mono-phase square pulse wave 11.7cm(L) x 6.6cm(W) x 28.5cm(H) 94 g (without battery) 15, 30,60 minutes or Continue Bursts occur twice very second.pulse width(adjustable), pulse rate = 100 Hz, Burst rate=0.5hz The pulse rate and pulse width are adjustable. It generates continuous stimulation based on the setting value. Modulation 1 mode is a pulse width modulation. The pulse width is automatically varied in a cycle pattern over an interval of nominally 10 Seconds. Pulse width increase over a period of 5 seconds from 30 us to the control setting value, then decreases over a 5 seconds period to its original value (30 us). The cycle is then repeated. 17
14 15 Modulation 2 mode (M2) SD mode (SD) Modulation 2 mode is a pulse rate modulation. The pulse rate is automatically varied in a cycle pattern over an interval of nominally 10 Seconds. Pulse rate decreases over a period of 5 seconds from the control setting value to a value which is 40% less, then increase over a 5 seconds period to its original value. The cycle is then repeated. The SD (Strength-Duration) mode consists of automatic modulation intensity and pulse width in 70% range. The intensity is always increasing while the pulse width is decreasing and vice versa. The intensity is decreased by 70% while the pulse width is increased by 70% in 5 seconds. In the next 5 seconds, the intensity is increased by 70% while the pulse width is decreased by 70%. Total cycle time is 10 seconds. Pulse rate (2~150Hz) and pulse width (30 ~ 260μS) are fully adjustable. 18
5.2 The waveforms of the stimulation programs Burst(B) Normal (N) 2 Burst per second 10 pulses per Burst Pulse Width Modulation Cycle time Pulse Rate Modulation Cycle time SD (Strength-Duration) 10 seconds 19
6. PROGRAM Mode Program B N TENS M1 M2 SD Modulation Method Burst Continuous Pulse width modulation Pulse rate modulation Strength- Duration Frequency 100Hz Burst:0.5Hz 2-150Hz 2-150Hz 2-150Hz 2-150Hz Pulse Width Treatment time 30-260us 15, 30, 60min,continuous 30-260us 15, 30, 60min,continuous 30-260us 15, 30, 60min,continuous 30-260us 15, 30, 60min,continuous 30-260us 15, 30, 60min,continuous 7. CLEANING AND CARE 7.1 Tips for skin care 1) 2) (anterior neck) or transcerebrally (through the head). 3) 4) 5) 20
6) 7) 8) (anterior neck) or transcerebrally (through the head 7.2 Cleaning the device 1) 2) 3) (anterior neck) or transcerebrally (thro 7.3 Electrodes 1) 2) (anterior neck) or transcerebrally (through th 3) Adhesive Pad Connector for inserting Lead wire Pin Reusable, Self-adhering electrodes 21
To use these electrodes 1) 2) 3) (anterior neck) or transcerebrally (through the head) To remove your electrodes 1) 2) 3) (anterior neck) or transcerebrally (throu CAUTION: 1) 2) 3) 4) (anterior neck) or transcerebrally (through the h 5) 6) 7) 22
7.4 Cleaning the Electrodes cords 7.5 Maintenance 1) 2) 3) (anterio neck) or transcereb ally (through the he 4) 23
8. TROUBLESHOOTING Problem Possible Cause Solution LED indicator fail to light up Stimulation weak or cannot feel any stimulation Stimulation is uncomfortable Intermittent output Battery contact failure Electrodes 1. Dried out or contaminated 2. Placement Lead wires Old/worn/damaged Intensity is too high Electrodes are too close together Damaged or worn electrodes or lead wires Electrode active area size is too small. Mayn't operate the device according to the manual. Lead wires 1. Try fresh batteries. 2. Ensure batteries are inserted correctly. Check the following contacts: All contacts are in place. All contacts are not broken. Replace and re-connect Replace Decrease intensity. Reposition the electrodes. Replace. Replace electrodes with ones that have an active area no 2 less than 16.0cm (4cm*4cm). Please check the manual before use. 1. Verify connection is secure. Insure firmly. 2. Turn down the intensity. Rotate lead wires in socket 90. If still intermittent, replace lead wire. 3. If still intermittent after replacing lead wire, a component may have failed. Call the repair department. 24
Stimulation is ineffective. The skin becomes red and/or you feel a stabbing pain Output current stops during therapy Improper electrode and applicator placement Unknown Use the electrodes on the same site every time. The electrodes aren't stuck onto the skin properly. The electrodes are dirty. The surface of the electrode was scratched. The electrode pads come off the skin. The cable is disconnected The power of the batteries has been exhausted. 4.Some programs will seem intermittent. This is expected. Reposition electrode and applicator Contact clinician. Re-position the electrodes. If at any time you feel pain or discomfort stop use immediately. Ensure the electrode is stuck securely on the skin. Clean the electrode pads with a damp, lint free cloth or replace new electrode pads. Replace new electrode. Turn off the device and stick the electrode pad firmly to the skin. Turn off the device and connect the cable Please replace them with new batteries. 25
9. MAINTENANCE AND CAUTIONS 1) 2) 3) 4) 5) 6) 7) Do not immerse device in water or any liquid. Do not drop the device or throw it from a height. After using the device, please remove the output plug from the output socket and re-attach the electrode pads to the protective transparent film. Always use the protective film when the pads are not in use. Do not twist or pull the output cable. Do not use any chemical to clean the main unit or the electrodes. If you need to clean them, please wipe with a damp, lint free cloth. Do not let the pad dry out or expose to sunlight. Keep the electrode pad clean. 10. STORAGE 1) 2) 3) 4) 5) 6) 7) Remove the batteries from the unit if you are not going to use it for a long period of time. Leaking batteries can damage the unit. Do not make any sharp kinks in the connecting leads or electrodes. After use, stick the electrode pad onto the protective plastic film. Do not expose the device to direct sunlight and protect it against dirt and moisture. Store the device in a cool, well- ventilated place. Never place any heavy objects on the device. 26
11. DISPOSAL Used fully discharged batteries must be disposed of in a specially labeled collection container, at toxic waste collection points or through an electrical retailer. You are under legal obligation to dispose of batteries correctly. Please dispose of the device in accordance with the legal obligation. 12. GLOSSARY OF SYMBOLS Batch code Serial number Attention: Read the operating instruction before use! Electrical devices are recyclable material and should not be disposed of with household waste after their useful life! Help us to protect the environment and save resources and take this device to the appropriate collection points. Please contact the organization which is responsible for waste disposal in your area if you have any questions. Type BF Applied Part 13. WARRANTY This product is guaranteed for a period of one year from the date of purchase against mechanical and electrical manufacturing defects. There are no user serviceable parts inside the instrument. Any attempted repair by unauthorized persons invalidates the warranty. This does not affect your statutory rights. 27
Manufactured for: TM Current Solutions LLC 3814 Woodbury Drive Austin,TX 78704 Ph:(800)871-7858 www.currentsolutionsnow.com